TriangleNCT02357147 · OUTCOME
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Baseline up to 3 years
What was measured
AEs included both non-SAEs and SAEs and the same participant can have both SAEs and as well non-SAEs.
Analysis population: The safety analysis set was defined as all randomized participants who received at least 1 dose of study drug.
Groups in this outcome
Combination Treatment Phase:Amatuximab + Pemetrexed +Cisplatin
During Combination Treatment Phase, participants received amatuximab 5 mg/kg, infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles.
Combination Treatment Phase: Placebo + Pemetrexed + Cisplatin
During Combination Treatment Phase, participants received placebo matched to amatuximab infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles.
Maintenance Treatment Phase: Amatuximab
Following completion of the Combination Treatment Phase, participants who had not progressed entered the Maintenance Phase and continued to receive amatuximab 5 mg/kg, infusion, intravenously, once weekly until disease progression.
Maintenance Treatment Phase: Placebo
Following completion of the Combination Treatment Phase, participants who had not progressed entered the Maintenance Phase and received placebo matched to amatuximab infusion, intravenously, once weekly until disease progression.
| Group | Source count |
|---|---|
| Combination Treatment Phase:Amatuximab + Pemetrexed +Cisplatin | 52 |
| Combination Treatment Phase: Placebo + Pemetrexed + Cisplatin | 54 |
| Maintenance Treatment Phase: Amatuximab | 25 |
| Maintenance Treatment Phase: Placebo | 29 |
Reported measurements
AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination Treatment Phase:Amatuximab + Pemetrexed +Cisplatin | 50 | Not reported | Not reported | Not reported | Not reported |
| Combination Treatment Phase: Placebo + Pemetrexed + Cisplatin | 52 | Not reported | Not reported | Not reported | Not reported |
| Maintenance Treatment Phase: Amatuximab | 19 | Not reported | Not reported | Not reported | Not reported |
| Maintenance Treatment Phase: Placebo | 21 | Not reported | Not reported | Not reported | Not reported |
SAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination Treatment Phase:Amatuximab + Pemetrexed +Cisplatin | 15 | Not reported | Not reported | Not reported | Not reported |
| Combination Treatment Phase: Placebo + Pemetrexed + Cisplatin | 11 | Not reported | Not reported | Not reported | Not reported |
| Maintenance Treatment Phase: Amatuximab | 1 | Not reported | Not reported | Not reported | Not reported |
| Maintenance Treatment Phase: Placebo | 4 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 50
- group Id
- OG001
- value
- 52
- group Id
- OG002
- value
- 19
- group Id
- OG003
- value
- 21
- title
- AEs
- categories
- measurements
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 11
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 4
- title
- SAEs
- denoms
- counts
- group Id
- OG000
- value
- 52
- group Id
- OG001
- value
- 54
- group Id
- OG002
- value
- 25
- group Id
- OG003
- value
- 29
- units
- Participants
- description
- AEs included both non-SAEs and SAEs and the same participant can have both SAEs and as well non-SAEs.
- groups
- description
- During Combination Treatment Phase, participants received amatuximab 5 mg/kg, infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles.
- id
- OG000
- title
- Combination Treatment Phase:Amatuximab + Pemetrexed +Cisplatin
- description
- During Combination Treatment Phase, participants received placebo matched to amatuximab infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles.
- id
- OG001
- title
- Combination Treatment Phase: Placebo + Pemetrexed + Cisplatin
- description
- Following completion of the Combination Treatment Phase, participants who had not progressed entered the Maintenance Phase and continued to receive amatuximab 5 mg/kg, infusion, intravenously, once weekly until disease progression.
- id
- OG002
- title
- Maintenance Treatment Phase: Amatuximab
- description
- Following completion of the Combination Treatment Phase, participants who had not progressed entered the Maintenance Phase and received placebo matched to amatuximab infusion, intravenously, once weekly until disease progression.
- id
- OG003
- title
- Maintenance Treatment Phase: Placebo
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The safety analysis set was defined as all randomized participants who received at least 1 dose of study drug.
- reporting Status
- POSTED
- time Frame
- Baseline up to 3 years
- title
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice